Results from first head-to-head study comparing Toujeo® to insulin degludec

Gla-300 met primary endpoint in lowering blood sugar levels and was non-inferior to insulin degludec in adults with type 2 diabetes not previously on insulin, the research found.

Incidence and rate of low blood sugar events were reduced with Gla-300 in the first 12 weeks compared to insulin degludec, and comparable from weeks 13-24 and the full 24-week study period, Sanofi said.

Results of the study, called BRIGHT, were presented today at the American Diabetes Association (ADA) 78th Scientific Sessions in Orlando, Florida, US.

In the study, involving nearly 1,000 people with type 2 diabetes, Gla-300 met its primary endpoint of non inferior reduction in HbA1c levels versus insulin degludec (at a non-inferiority margin of 0.3 per cent and difference between treatments: -0.05 per cent [95 per cent CI −0.15 to 0.05 per cent ]). Gla-300 also demonstrated a lower rate of ‘anytime (24h) hypoglycemia’ in the first 12 weeks, the sensitive period in which patients and healthcare professionals work to determine the most appropriate individual dose.

These promising results add reassurance to both patients and healthcare professionals during the critical early treatment period and provide further confidence for controlling their blood sugar in the future. Professor Jeffrey Stephens

During this initial phase, Gla-300 lowered both confirmed incidence of hypoglycemia (low blood sugar events) and the rate (number of events) of ‘anytime (24h) hypoglycaemia’ (defined as (≤70 mg/dL). At that time, Gla-300 reduced the incidence of hypoglycaemia by 26 per cent and rate by 23 per cent compared to insulin degludec.

The incidence of hypoglycaemia (<70mg/dl) during the full 24 week study period was comparable between Gla-300 and insulin degludec (66.5 vs 69 per cent respectively).

Professor Jeffrey Stephens, clinical professor of diabetes at Swansea University, said: “Hypoglycaemia is a concern for people with diabetes mainly in the initial period of dose adjustment and can lead to poor medium-term blood sugar control or discontinuation of treatment. These promising results add reassurance to both patients and healthcare professionals during the critical early treatment period and provide further confidence for controlling their blood sugar in the future.”

Results of the BRIGHT study:

The randomised controlled trial compared the efficacy and safety of Toujeo® (Gla-300) versus insulin degludec at 24 weeks. The study randomised 929 adults with type 2 diabetes to once-dailyGla-300 or insulin degludec 100 units/mL. Before randomisation, participants were inadequately controlled with tablets (oral anti-hyperglycemic drugs, OADs), with or without a glucagon-like peptide-1 (GLP-1) receptor agonist, and had not previously started insulin therapy.

The study met its primary endpoint of non inferior reduction in blood sugar (HbA1c) levels for Gla-300 versus insulin degludec, from baseline to week 24 (at a non-inferiority margin of 0.3 per cent and difference between treatments: -0.05 per cent [95 per cent CI −0.15 to 0.05 per cent]).

Over the 24-week period, incidence and event rates of confirmed (≤70 mg/dL and ≤54 mg/dL) hypoglycemia at any time of day were similar between Gla-300 and insulin degludec. During the titration period (0-12 weeks), confirmed hypoglycemia event rates were lower by 23 percent (≤70 mg/dL) and 43 percent (≤54 mg/dL), respectively. In this period, the incidence of confirmed low blood sugar were also reduced by 26 per cent (≤70 mg/dL) and 37 per cent (≤54 mg/dL). Hypoglycemia incidence and event rates were similar in the maintenance time period (13-24-week).1